SBIR-STTR Award

Each year, ~200,000 newborns worldwide, 80-85% of whom require surgical intervention, are afflicted with congenital conditions that cause impaired growth of the skull or mandible, leading to abnormalities that affect breathing, hearing, speech, visual function, neurologic development, and mastication. Unfortunately, current surgical treatments, including endoscopic surgery, open reconstruction, and distraction osteogenesis (DO), suffer inherent drawbacks, impacting outcomes. A better solution is needed for this vulnerable patient population. DO is a widely recognized treatment modality that harnesses the body’s natural ability to regenerate bone in order to correct skeletal deficiencies and defects. While still emerging for craniomaxillofacial (CMF) applications, surgeons have shown the utility of DO for restoring functional discrepancies in patients with craniofacial differences. The technique of DO involves surgical placement of one or more distractors, which are devices used to slowly separate two opposing bony fragments at an osteotomy site, to gradually lengthen and reshape the affected bone and stimulate new bone growth. However, DO is not without shortcomings. First, all current distractors have an external component for manual expansion. The external component significantly increases patient risk for complications such as infection (35%), device dislodgement (3.0%), increased analgesic use, and scarring (15.6%). Second, since the burdensome responsibility for manual expansion lies with the caregiver, treatment noncompliance (4.7%) is a serious issue, introducing vulnerabilities ranging from inconsistent device expansion to complete treatment failure. Therefore, DO necessitates extensive physician clinic time and patient radiation exposure to monitor therapeutic progress and thus has not been widely adopted in the CMF skeleton despite recognition of potential advantages over endoscopic surgery (narrower indication for use) and open reconstruction (more invasive, longer anesthesia time, higher blood transfusion rate, longer hospital stay). The Ostiio distraction (OD) system addresses many of the issues associated with DO treatment as the first fully subcutaneous, contactless DO system for the CMF skeleton. At a high level, the OD system leverages magnetic coupling to transfer torque from the hand-held driver (HHD) to the implant, thereby expanding the implant in a contactless fashion. This novel approach will markedly reduce infection, scarring, and manipulation noncompliance. In addition, because the design uniquely permits wireless communication between the implant and HHD, it will enable physicians to better control and monitor treatment progress. This proposal aims to validate a key performance spec of the OD system by demonstrating it can rigorously meet distraction force performance parameters similar to those achieved by the current standard of care. Successful demonstration of this outcome will support Phase II in which we will further development of the OD system by validating function and performance in an in vivo model and formative human factors study. This work will speed to market a novel approach to CMF surgery that can significantly improve DO patient outcomes and experience. Public Health Relevance Statement NARRATIVE Each year, ~200,000 newborns worldwide, 80-85% of whom require surgical intervention, are afflicted with congenital conditions that cause impaired growth of the skull or mandible, leading to abnormalities that affect breathing, hearing, speech, visual function, neurologic development, and mastication. Distraction osteogenesis (DO) is a widely recognized treatment modality for craniofacial abnormalities that harnesses the body’s natural ability to regenerate bone in order to correct skeletal deficiencies and defects. While surgeons have shown the utility of DO for restoring functional discrepancies in patients born with craniofacial differences, the technique has not been widely adopted due to numerous limitations of current DO systems stemming from their semi- buried design and burdensome reliance on caregivers to follow precise treatment protocols. The Ostiio distraction (OD) system addresses many of these issues as the first fully subcutaneous, contactless DO system for the CMF skeleton, thereby markedly reducing potential for infection, scarring, and manipulation noncompliance.

Project Terms:
Affect ; Analgesics ; Analgesic Agents ; Analgesic Drugs ; Analgesic Preparation ; Anodynes ; Antinociceptive Agents ; Antinociceptive Drugs ; pain killer ; pain medication ; pain reliever ; painkiller ; Anatomy ; Anatomic ; Anatomic Sites ; Anatomic structures ; Anatomical Sciences ; Anesthesia procedures ; Anesthesia ; Breathing ; Respiratory Aspiration ; Respiratory Inspiration ; inspiration ; Automobile Driving ; driving ; Back ; Dorsum ; Blood Transfusion ; bone ; Bone Regeneration ; bone repair ; regenerate bone ; Cicatrix ; Scars ; Canis familiaris ; Canine Species ; Dogs ; Dogs Mammals ; canine ; domestic dog ; Engineering ; Growth ; Generalized Growth ; Tissue Growth ; ontogeny ; Hand ; Hearing ; Human ; Modern Man ; 0-4 weeks old ; Newborns ; newborn child ; newborn children ; Newborn Infant ; Infection ; Number of Days in Hospital ; hospital days ; hospital length of stay ; hospital stay ; Length of Stay ; Inferior Maxillary Bone ; mandibular ; Mandible ; Manuals ; Chewing ; chewed ; chews ; Mastication ; Methodology ; Osteotomy ; Patients ; Pennsylvania ; Physicians ; Rotation ; Skull ; cranium ; Software ; Computer software ; Speech ; Steel ; Testing ; Time ; Treatment Regimen ; Treatment Schedule ; Treatment Protocols ; Universities ; Sight ; visual function ; Vision ; Work ; Measures ; MT-bound tau ; microtubule bound tau ; microtubule-bound tau ; tau ; tau factor ; τ Proteins ; tau Proteins ; Care Givers ; Caregivers ; Dataset ; Data Set ; therapy failure ; Treatment Failure ; Friction ; improved ; Site ; Phase ; Neurological ; Neurologic ; soft tissue ; Sample Size ; Therapeutic ; Exposure to ; Torque ; craniofacial anomalies ; craniofacial defects ; craniofacial malformation ; Craniofacial Abnormalities ; Bone Tissue ; Adopted ; Dimensions ; Clinic ; subdermal ; subcutaneous ; Techniques ; System ; Test Result ; non-compliant ; noncompliance ; noncompliant ; non-compliance ; skeletal ; Distraction Osteogenesis ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; magnetic ; Magnetism ; Surgeon ; craniofacies ; craniofacial ; experience ; Performance ; success ; plastic surgery ; Plastic Surgical Procedures ; Speed ; Modality ; Devices ; Skeleton ; Bone Growth ; Skin ; distraction ; Address ; Defect ; in vivo ; in vivo Model ; Patient outcome ; Patient-Centered Outcomes ; Patient-Focused Outcomes ; Validation ; Monitor ; developmental ; Development ; craniomaxillofacial ; cost ; reconstruction ; design ; designing ; novel strategies ; new approaches ; novel approaches ; novel strategy ; Outcome ; Coupling ; Impairment ; Implant ; stem ; prototype ; patient population ; standard of care ; Patient risk ; improved outcome ; Radiation exposure ; experimental study ; experiment ; experimental research ; manufacturability ; wireless communication ; sheep model ; ovine animal model ; ovine model ;

Each year, ~200,000 newborns worldwide, 80-85% of whom require surgical intervention, are afflicted withcongenital conditions that cause impaired growth of the skull or mandible, leading to abnormalities that affectbreathing, hearing, speech, visual function, neurologic development, and mastication. Unfortunately, currentsurgical treatments, including endoscopic surgery, open reconstruction, and distraction osteogenesis (DO),suffer inherent drawbacks, impacting outcomes. A better solution is needed for this vulnerable patient population.DO is a widely recognized treatment modality that harnesses the body's natural ability to regenerate bone inorder to correct skeletal deficiencies and defects. While still emerging for craniomaxillofacial (CMF) applications,surgeons have shown the utility of DO for restoring functional discrepancies in patients with craniofacialdifferences. The technique of DO involves surgical placement of one or more distractors, which are devicesused to slowly separate two opposing bony fragments at an osteotomy site, to gradually lengthen and reshapethe affected bone and stimulate new bone growth. However, DO is not without shortcomings. First, all currentdistractors have an external component for manual expansion. The external component significantly increasespatient risk for complications such as infection (35%), device dislodgement (3.0%), increased analgesic use, andscarring (15.6%). Second, since the burdensome responsibility for manual expansion lies with the caregiver,treatment noncompliance (4.7%) is a serious issue, introducing vulnerabilities ranging from inconsistent deviceexpansion to complete treatment failure. Therefore, DO necessitates extensive physician clinic time and patientradiation exposure to monitor therapeutic progress and thus has not been widely adopted in the CMF skeletondespite recognition of potential advantages over endoscopic surgery (narrower indication for use) and openreconstruction (more invasive, longer anesthesia time, higher blood transfusion rate, longer hospital stay).The Ostiio distraction system addresses many of the issues associated with DO treatment as the first fullysubcutaneous, programmable DO system for the CMF skeleton. At a high level, the Ostiio distraction systemleverages magnetic coupling to transfer torque from the hand-held driver (HHD) to the implant, therebyexpanding the implant in a contactless fashion. This novel approach will markedly reduce infection, scarring, andmanipulation noncompliance. In addition, because the design uniquely permits wireless communication betweenthe implant and HHD, it will enable physicians to better control and monitor treatment progress.This Phase II proposal aims to a) achieve design freeze of the integrated Ostiio distraction system, incorporatingdesign improvements to ensure device biocompatibility and functionality throughout active distraction, and b)demonstrate the system can be used safely and effectively to perform a complete distraction protocol in vivo instandard animal model. Successful demonstration of this outcome will satisfy key validation performance testingrequirements for FDA submission and 510(k) clearance and open a path to widespread clinical adoption.

Public Health Relevance Statement:
NARRATIVE Each year, ~200,000 newborns worldwide, 80-85% of whom require surgical intervention, are afflicted with congenital conditions that cause impaired growth of the skull or mandible, leading to abnormalities that affect breathing, hearing, speech, visual function, neurologic development, and mastication. Distraction osteogenesis (DO) is a widely recognized treatment modality for craniofacial abnormalities that harnesses the body's natural ability to regenerate bone in order to correct skeletal deficiencies and defects. While surgeons have shown the utility of DO for restoring functional discrepancies in patients born with craniofacial differences, the technique has not been widely adopted due to numerous limitations of current DO systems stemming from their semi- buried design and burdensome reliance on caregivers to follow precise treatment protocols. The Ostiio distraction system addresses many of these issues as the first fully subcutaneous, contactless DO system for the CMF skeleton, thereby markedly reducing potential for infection, scarring, and manipulation noncompliance.

Project Terms:
<0-4 weeks old>